India Ink, for Cryptococcus, Dropper Bottle, 15ml, by Hardy Diagnostics

Hardy Diagnostics India Ink is recommended for use in the identification of Cryptococcus neoformans. The use of India Ink is not technically a staining method. The polysaccharide capsule of encapsulated organisms (e.g., Cryptococcus neoformans) excludes the ink particles. Organisms are detected by the appearance of a distinctive halo surrounding the encapsulated fungi. Care in interpretation is required because artifacts (e.g., leukocytes, erythrocytes, powder, bubbles) may be confused with yeast cells. The morphologic characteristics of the yeast cells must be recognized before the preparation can be interpreted. This product is for in vitro diagnostic use only. It is to be used only by adequately trained and qualified laboratory personnel. The Hardy Diagnostics manufacturing facility and quality management system comply with the FDA's Good Manufacturing Practices (GMP) and have achieved ISO 13485 certification as a medical device manufacturer.